Medical device recalls Moderate risk

LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLC recalls REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue f…

Recall date
August 8, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0823-2018
FDA classification
Class II
Brand / firm
LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLC
Sold / distributed
US Nationwide, Canada, Australia, Chile, Brazil, Israel, Japan New Zealand & Singapore

Why it was recalled

Presence of bacterial endotoxins levels above the acceptable limit

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring.

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